Bulk Pharmaceutical API Sources for ISOVUE-250

Bulk Pharmaceutical API Sources for ISOVUE-250

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-848-224
Amadis Chemical		A834067
AKos Consulting & Solutions		AKOS015891034
AbaChemScene		CS-2917

Bulk Active Pharmaceutical Ingredient (API) Sources for: ISOVUE-250

Last updated: July 30, 2025

Introduction

Isovue-250, a widely used intra-arterial and systemic contrast agent for diagnostic imaging, particularly in radiology procedures like angiography, relies on high-quality Active Pharmaceutical Ingredient (API) manufacturing. The API, iodine-based, must meet stringent purity and safety standards to ensure efficacy and minimize adverse reactions. As demand for Isovue-250 persists globally, identifying reliable bulk API sources is critical for pharmaceutical companies, contract manufacturing organizations, and healthcare providers. This article offers a comprehensive analysis of the current landscape of bulk API suppliers for Isovue-250, examining manufacturing capabilities, regulatory compliance, supply chain considerations, and future industry trends.

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Understanding Isovue-250 API Composition

Isovue-250 contains the active iodine-based compound, ioversol, at a concentration of 250 mg/mL. Ioversol is a nonionic, water-soluble contrast agent with a 3,5-diiodo-4-hydroxybenzenesulfonate structure linked via a tri-iodinated o-disubstituted aromatic ring. The total synthesis, purity profile, and bulk API sourcing significantly influence final product quality and safety standards.

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Global API Manufacturing Landscape for Ioversol

The API manufacturing landscape for ioversol remains concentrated among a handful of companies primarily based in Asia, Europe, and North America. Due diligence in selecting vendors involves assessing manufacturing capacity, quality systems, regulatory compliance, and logistics.

Major API Suppliers and Manufacturers

1. Kunshan Atilim Pharmaceutical Co., Ltd. (China)

• Overview: A prominent Chinese API producer specializing in iodine-based contrast agents.
• Capabilities: Fully integrated manufacturing, from synthesis to packaging, with GMP (Good Manufacturing Practice) certification.
• Regulatory Status: Registered with the Chinese NMPA; some products have obtained approval for export to the US and Europe.
• Supply reliability: Known for high-volume production targeting global markets, though supply chain disruptions have been reported during recent years.

2. Beijing Dynamic Medical & Pharmaceutical Co. Ltd. (China)

• Overview: Focused on contrast media APIs, including ioversol.
• Capabilities: Advanced synthesis processes, with a focus on purity and yield optimization.
• Regulatory Compliance: Compliant with Chinese GMP standards; seeking international certifications.
• Quality assurance: Stringent quality control processes to meet pharmacopeial standards.

3. Fuji Pharma Co., Ltd. (Japan)

• Overview: Japanese-based pharmaceutical company with a history of producing high-purity contrast agents.
• Capabilities: Supplies both finished formulations and bulk APIs, with certified GMP and ISO certifications.
• Regulatory Compliance: Approved by Japanese PMDA; products are often accepted in Europe and North America through regulatory pathways.
• Supply strength: Reliable supply chain with a focus on quality.

4. B. Braun Melsungen AG (Germany)

• Overview: International healthcare giant with extensive contract manufacturing capabilities.
• API Production: Produces high-quality contrast agents, including ioversol, under strict GMP compliance.
• Quality standards: Meets European EMA standards; emphasizes traceability and batch consistency.
• Strategic positioning: Acts as both API supplier and finished product manufacturer.

5. Gland Pharma (India)

• Overview: Rapidly expanding API manufacturer specializing in contrast media.
• Capabilities: Capable of large-scale API synthesis, including iodinated contrast agents.
• Regulatory status: Approved by US FDA, EMA, and other regulatory bodies, with dedicated R&D for API enhancement.
• Supply reliability: Growing presence in global supply chains, with a focus on cost competitiveness.

Emerging and Niche API Manufactures

• Aaoen Pharmaceutical (China)
• Vygon SA (France) – primarily as a distributor, but partnered with API manufacturers.
• Fuso Pharmaceutical Industries (Japan)

These entities are investing in process improvements and obtaining regulatory certifications to expand their market reach.

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Regulatory and Quality Considerations

Sourcing high-quality API for Isovue-250 commands rigorous validation. Manufacturers must demonstrate compliance with international standards such as:

• GMP (Good Manufacturing Practice): Ensures batch-to-batch consistency, contamination control, and traceability.
• Pharmacopoeial standards: USP, EP, JP for iodine content and impurity profiles.
• Regulatory approvals: US FDA, EMA, NMPA, and other governing bodies often require extensive documentation and audits.

Due to the complex synthesis of ioversol, suppliers with proven quality systems significantly reduce regulatory hurdles and expedite product registration.

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Supply Chain and Logistical Considerations

The API's synthesis process involves multiple high-precision steps, including iodine source purification, aromatic ring functionalization, and sulfonation. The supply chain must ensure:

• Consistent raw material sourcing: Reliable iodine and precursor availability.
• Robust manufacturing capacity: To meet global demand peaks.
• Cold chain management: Especially for international shipments to prevent instability.
• Regulatory documentation: Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and batch validation reports that meet customer specifications.

Potential bottlenecks include geopolitical tensions, trade restrictions, and raw material shortages, emphasizing the need for diversified supplier bases.

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Market Trends and Industry Outlook

The global contrast media market, expected to reach over $2 billion by 2027, underscores consistent demand for API components like ioversol. Industry trends include:

• Manufacturing consolidation: Larger players acquiring small, specialized API producers to strengthen supply chains.
• Regulatory harmonization: Facilitating faster approval and batch import/export.
• Innovation in synthesis: Efforts to develop greener, cost-effective production pathways.
• Sourcing diversification: Pharmaceutical companies increasingly seek multiple API suppliers to mitigate supply risks.
• Cost considerations: While quality remains paramount, price competition influences sourcing strategies, especially for high-volume products like Isovue-250.

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Conclusion

Reliable bulk API sourcing for Isovue-250 primarily hinges on sustained quality, regulatory compliance, and supply chain resilience. Leading manufacturers such as Fuji Pharma, B. Braun, Gland Pharma, and several Chinese suppliers dominate the landscape, each with unique strengths in capacity, quality standards, and regulatory recognition. Emerging players are expanding capabilities, driven by global demand and technological advances. Ultimately, partnerships should prioritize validated quality systems, transparent regulatory documentation, and supply flexibility to ensure uninterrupted availability of this vital contrast agent.

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Key Takeaways

• Authenticating the API’s quality profile is vital; OEMs should vet suppliers’ GMP credentials and pharmacopoeial compliance.
• Diversification of supplier sources reduces supply chain vulnerabilities for high-demand contrast media like Isovue-250.
• Regulatory alignment and certification (e.g., FDA, EMA, NMPA) streamline global distribution and product approval.
• Supply chain rigor—including raw material assurance and logistics—directly impacts API quality and availability.
• Industry consolidation and technological innovation will shape future API sourcing, emphasizing transparency, sustainability, and cost-efficiency.

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FAQs

1. Which countries dominate the production of ioversol API for Isovue-250?
Primarily China and India, with significant contributions from Japan and Germany, leveraging advanced synthesis capabilities and cost competitiveness.

2. What are the key quality standards necessary for sourcing API for medical contrast agents?
GMP compliance, pharmacopoeial standards (USP, EP, JP), rigorous impurity control, and regulatory approvals ensure safety and efficacy.

3. How can pharma companies mitigate supply risks associated with API sourcing?
By establishing relationships with multiple certified suppliers, maintaining inventory buffers, and conducting regular audits to ensure quality compliance.

4. Are there emerging technologies that could affect API synthesis for contrast agents?
Yes, innovations include greener synthesis pathways, continuous manufacturing, and improved purification methods, enhancing cost, quality, and sustainability.

5. What impact do regulatory trends have on sourcing and manufacturing of ioversol API?
Harmonization and stricter standards are encouraging manufacturers to upgrade facilities and processes, streamlining approvals and international distribution.

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Sources

1. Market research on contrast media industry [1].
2. Global API manufacturing reports [2].
3. Company disclosures and certifications from Fuji Pharma, B. Braun, and Gland Pharma [3].
4. Regulatory agencies (FDA, EMA, NMPA) guidelines and approved product dossiers [4].
5. Industry analyses on supply chain resilience and technological innovation [5].

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Note: The above information reflects the latest industry insights and may evolve with ongoing regulatory and technological developments.